Monday, July 09, 2007

FDA Gave Glaxo Extra Year to Profit Off Avandia

A February 22, 2006 internal FDA memorandum, obtained by staffers of the Senate Finance Committee, proves that safety officials within the agency recommended that GlaxoSmithKline add a black box warning about congestive heart failure to the label of the diabetes drug Avandia well over a year ago.

The memo also shows that FDA reviewer Dr David Ross recommended a highlighted boxed warning for CHF, a life-threatening condition that occurs when fluid builds up in the lungs causing a severe shortness of breath that requires immediate medical attention.

The memo also recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event on the label.